Category: Flavors

  • Mixed Reactions to Menthol and Cigar Flavors Plan

    Mixed Reactions to Menthol and Cigar Flavors Plan

    Photo: Alicia

    The U.S. Food and Drug Administration’s recently announced plan to ban menthol in cigarettes and characterizing flavors in cigars has evoked mixed reactions among stakeholders.

    The Campaign for Tobacco-Free Kids welcomed the move. “By issuing proposed rules today to prohibit menthol cigarettes and all flavored cigars, the FDA is taking historic and long-overdue action to protect our nation’s kids, advance health equity and save lives, especially among Black Americans and other populations that have been targeted by the tobacco industry and suffered enormous harm from the predatory marketing of these products,” the organization wrote in a statement.

    The Foundation for a Smoke-Free World (FSW), which is backed by Philip Morris International, said the FDA’s move could become one of the most significant actions in the fight to end the smoking epidemic in the U.S.

    “Menthol cigarettes are disproportionately used by African Americans and prohibiting their sale would help address the health disparities caused by these products,” the organization wrote in a statement

    “Tobacco product use is the leading cause of preventable death in the U.S. African Americans smoke menthol cigarettes at a rate that is far higher than menthol use prevalence in other racial and ethnic groups. The FDA cites modeling studies that indicate if menthol cigarettes were no longer available, smoking rates and deaths due to smoking would decline significantly in the U.S.”

    While describing the menthol ban as an important step, the FSFW stressed that adult smokers who are addicted to menthol cigarettes and who cannot or will not quit entirely require support. “Menthol-flavored harm reduction products (e-cigarettes, nicotine replacement therapy gum, heated tobacco, and snus) provide users with access to alternatives to switching to nonmenthol combustibles or turning to the black market for menthol products,” the group wrote.

    We strongly believe that there are more effective routes to deliver tobacco harm reduction than banning menthol in cigarettes.

    Kingsley Wheaton, chief marketing officer, BAT

    British American Tobacco said it was reviewing the details of the proposed regulations and would continue to actively participate in the rulemaking process by submitting science-based comments to the FDA.

    “We strongly believe that there are more effective routes to deliver tobacco harm reduction than banning menthol in cigarettes,” said BAT Chief Marketing Officer Kingsley Wheaton in a statement. “Evidence from other markets, including Canada and the EU where similar bans have been imposed, demonstrates little impact on overall cigarette consumption.

    “The scientific evidence shows no difference in the health risks associated with menthol cigarettes compared to non-menthol cigarettes, nor does it support that menthol cigarettes adversely affect initiation, dependence or cessation. As a result, we do not believe the published science supports regulating menthol cigarettes differently from non-menthol cigarettes.”

    22nd Century Group is confident its VLN Menthol King brand will be exempted from the FDA ban.
    (Photo: 22nd Century Group)

    22nd Century Group, meanwhile, expressed support for the FDA’s proposed menthol ban, saying it expected its VLN Menthol King reduced nicotine cigarettes to be exempted from the FDA ban. On Dec. 23, 2021, the FDA authorized 22nd Century Group’s VLN Menthol King brand to be marketed with modified-risk claims.

    In its press release announcing that decision, the FDA acknowledged its menthol plans, stating, “In reaching today’s determination [authorizing the MRTP applications for VLN], the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products are ‘appropriate for the protection of public health’ and could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day,” according to 22nd Century Group.

    “Removing menthol from highly addictive cigarettes is a crucial public health step by the FDA, and we welcome today’s announcement,” said John Pritchard, vice president of regulatory science for 22nd Century, in a statement.

    “At the same time, we recognize, as the FDA has, that many adults who continue to smoke highly addictive cigarettes after the implementation of a final FDA rule will need access to suitably regulated alternative products. Our VLN products, including our recently authorized MRTP VLN Menthol King is an example of such a product, and we have already and will continue to represent our views to FDA on the importance of MRTP products in achieving FDA’s public health mission.”

    Stressing that the FDA’s April 28 announcement relates only to proposed product standards, Swisher, which is best known for its Swisher Sweets cigars, said it would continue business as usual. “The FDA announcement (…) is only a proposed rule and must go through a lengthy comment an approval process before it can be enacted,” the company wrote in a press note.

    Insisting there was little scientific evidence to support a ban on characterizing flavors in cigars, Swisher said it plans to vehemently oppose the measure with meaningful scientific and economic data.

  • Critics Slam ‘Misguided’ Menthol Ban

    Critics Slam ‘Misguided’ Menthol Ban

    Photo: Esser

    By Timothy S. Donahue

    The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.

    “The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”

    When finalized, the FDA states that the proposed menthol product standard will:

    • reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
    • improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation. 

    According to the FDA, the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.

    “This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”

    Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.

    Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many  markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.

    “They flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these– it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”

    Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.

    “There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”

    Guy Bentley

    Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.

    Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.

    Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.

    “It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”

    Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.

    The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards. 

    The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.

  • FDA Announces Plan for Menthol Ban

    FDA Announces Plan for Menthol Ban

    The U.S. Food and Drug Administration today announced a plan to ban the sale of menthol cigarettes in the United States. Menthols account for about one-third of the U.S. cigarette market.

    The agency expects that taking menthol cigarettes off the market will reduce smoking levels and lower the number of young people taking up the habit.

    “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” said U.S. Health and Human Services Secretary Xavier Becerra in a statement.  “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”

    With the FDA plan, the U.S. is following in the footsteps of Canada and the European Union, which banned menthol cigarettes in 2017 and 2020, respectively. Menthol is the only cigarette flavor that wasn’t banned under the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority over tobacco products.

    In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., with particularly high rates of use by youth, young adults and African American and other racial and ethnic groups, according to the FDA. The agency cited modeling studies suggesting that there would be a 15 percent reduction in smoking within 40 years if menthol cigarettes were no longer available in the U.S. These studies also estimate that 324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.

    Health advocates oppose menthol because the ingredient’s “cooling” effect makes it easier to start smoking and harder to quit. The health consequences have disproportionally fallen on Black smokers, 85 percent of whom use menthols.

    Critics have cautioned that a menthol ban could have unintended consequences. For example, Guy Bentley, director of consumer freedom at the Reason Foundation, warned of increased black market sales and more incarceration. The desired public health gains, he wrote, could also be achieved by applying the harm reduction model to tobacco policy.

    Along with its menthol ban, the FDA also announced product standards to prohibit all characterizing flavors (other than tobacco) in cigars.

    “Characterizing flavors in cigars, such as strawberry, grape, cocoa and fruit punch, increase appeal and make cigars easier to use, particularly among youth and young adults,” the FDA wrote in its announcement. “More than a half million youth in the U.S. use flavored cigars, and in recent years, more young people tried a cigar every day than tried a cigarette.”

    Beginning May 4, the public can provide comments on these proposed rules. The FDA also will convene public listening sessions on June 13 and June 15.

  • U.S. Industry Braces for Menthol Announcement

    U.S. Industry Braces for Menthol Announcement

    Photo: kasetch

    The U.S. Food and Drug Administration could announce a detailed proposal for phasing out menthol cigarettes as early as this week.

    On April 21, the White House concluded its review of FDA proposal to ban menthol cigarettes after nearly 40 virtual meetings with outside groups.

    According to an Associated Press report, dozens of interest groups have met with White House staffers to try to persuade them to oppose the proposal.

    Menthol is the only cigarette flavor that wasn’t banned under the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority over tobacco products. Menthol cigarettes account for more than one-third of the U.S. cigarette market.

    Health advocates oppose menthol because the ingredient’s “cooling” effect make it easier to start smoking and harder to quit. The health consequences have disproportionally fallen on black smokers, 85 percent of whom use menthols.

    In recent weeks, menthol ban opponents have stepped up their campaign against the proposed measure, meeting with lawmakers and publishing editorials. For example, earlier this month, Guy Bentley of the Reason Foundation warned that banned banning menthol cigarettes is a high-risk strategy.

    All major federal regulations—particularly those that could impact the economy—must be reviewed before publication by the White House Office of Management and Budget. Outside groups and individuals can request a meeting, offering a last chance to try and shape the final product.

    According to the Associated Press, more than half of the budget’s office on the menthol proposal were requested by group that traditionally oppose tobacco restrictions. Correspondence shows the groups raised concerns about unintended consequences of a ban, including increases in illegal market sales and increased policing of Black communities to contraband cigarettes.

    More than a quarter of meeting were reportedly requested by gas station owners, convenience stores and distributors. Members of the Southern Association of Wholesale Distributors, for example, said that some convenience stores could lose a third of their cigarette revenue, forcing them to close and create “food deserts”—geographical areas in which it is difficult to buy affordable or good-quality fresh food.

    Other groups, such as the Americans for Tax reform, which has received funding from Altria Group, warned of lost government revenue.

    Health advocates dismiss concerns about over-policing of Black communities and illicit sales. The proposed rules, they say, target distribution rather than possession, and most cigarette smuggling in the U.S. today is across state lines to take advantage of difference in tax rates. If menthol production stops, there will be little supply to smuggle, say health advocates. Canada banned menthol cigarettes in 2018.

  • Study: Menthol Ban Could Increase Lung Cancer Rates

    Study: Menthol Ban Could Increase Lung Cancer Rates

    Photo: New Africa

    Banning the sales of menthol cigarettes will likely have unintended consequences, according to a study by researchers from Vanderbilt University Medical Center published April 21 in the Journal of the National Cancer Institute .

    The U.S. Food and Drug Administration plans to issue proposed rules this spring that would prohibit menthol cigarettes. The measure is intended in part to address a health disparity since a significantly larger percentage of African Americans than whites smoke menthol cigarettes and African American men have higher lung cancer incidence and death rates from the disease.

    According to the FDA, nearly 85 percent of all non-Hispanic Black smokers smoke menthol cigarettes, compared to 30 percent of non-Hispanic white smokers. The agency also believes that menthol-flavored cigarettes can be more addictive than non-menthol cigarettes and harder to quit.

    However, the study by the Vanderbilt researchers revealed similar quit rates among menthol and non-menthol smokers overall and no statistically significant difference between white and African American participants.

    The researchers tracked 16,425 smokers who entered the study between 2002 and 2009 and completed a follow-up survey between 2008-2012, 2012-2015 and 2015-2017. The average annual quit rate from those surveys was 4.3 percent for menthol smokers and 4.5 percent for non-menthol smokers.

    Prior research by this Vanderbilt research group has shown that non-menthol smokers are at higher risk for lung cancer. They also cited research from Canada, where menthol-flavored cigarettes are banned, which revealed that most menthol smokers tend to switch to non-menthol brands rather than quit.

    “If the existing epidemiologic data showing lower risk of lung cancer among menthol than non-menthol smokers hold generally, then in the long-term if high percentages of menthol smokers switch to non-menthols, the ban could have the unintended consequence of a net increase rather than decrease in risk, at least for lung cancer,” the researchers noted in the study.

  • Critics: San Francisco Flavor Ban Study Flawed

    Critics: San Francisco Flavor Ban Study Flawed

    Photo: yossarian6

    New research refutes a May 2021 study suggesting San Francisco’s ban on all flavored tobacco products was tied to higher smoking rates in high school students compared to school districts without flavor policies in place, according to the Truth Initiative, an antitobacco organization.  

    Led by Harvard University’s School of Public Health’s Jessica Liu, the most recent research found that the data for the May 2021 study was collected too early to draw meaningful conclusions.

    The San Francisco ban on flavored tobacco went into effect in July 2018. Enforcement, however, did not start until January 2019, according to the authors of the Harvard study.

    The May 2021 study used data from the 2011-2019 Youth Risk Behavior Surveillance System (YRBSS) to determine smoking rates in youth after San Francisco’s flavor ban went into effect. However, the 2019 YRBSS data in San Francisco were collected between September and December 2018, before the flavor law was enforced.

    Given that compliance with flavored tobacco laws was relatively low in fall 2018 (17 percent in December 2018) and that few retailers were enforcing the restriction, data collected at this time are “an inappropriate data source for evaluating the effects of the city’s flavored tobacco sales restriction,” the authors write. “…the impact on actual access to flavored products did not really start to materialize until well after the YRBSS completed data collection in San Francisco.”

    Liu’s team also looked at Oakland, whose survey data on tobacco use in youth were collected after that city started enforcing a flavored tobacco ban in January 2019. Researchers observed that high school youth vaping and cigarette use declined between 2017 and 2019 in Oakland.

  • Bentley: Banning Menthol is a High-Risk Strategy

    Bentley: Banning Menthol is a High-Risk Strategy

    Guy Bentley

    The U.S. Food and Drug Administration’s plan to ban menthol cigarettes may have unintended consequences, such as increased black market sales and more incarceration, while doing little to advance public health, according to Guy Bentley, director of consumer freedom at the Reason Foundation.

    Writing on the organization’s website, Bentley says the desired public health gains could also be achieved by applying the harm reduction model to tobacco policy.

    In his article, Bentley examines the experiences of Canada, the European Union and Massachusetts, which have already banned menthol cigarettes, and finds the results to be underwhelming.

    “In the aggregate, the experience of menthol bans in the real world, as opposed to forecasts about them, is that the bans have minimal effects on tobacco consumption but do engender unintended consequences, even in markets where menthol is relatively unpopular,” he writes.

    According to Bentley, banning menthol cigarettes is a radical policy with significant implications for the criminal justice system and personal autonomy. “Rather than resorting to the failed policies of the past, the FDA and the Biden administration should apply the harm reduction model to tobacco policy,” he writes.

    “Educating the public and taking a harm reduction approach has been successful in the fields of sexual health and drug addiction, and it would be far more effective in reducing smoking than banning menthols.”

  • More Ads for Menthol E-Cigarettes

    More Ads for Menthol E-Cigarettes

    When the U.S. Food and Drug Administration banned flavored tobacco products, email and mailed advertisements for those products fell; however, ads for menthol-flavored products more than doubled, according to the Truth Initiative citing a Tobacco Control study.

    The study showed that partial flavor bans may not deter consumers, including youth, away from tobacco products. “Rather, manufacturers and consumers are adapting to new FDA regulations,” the study authors write. “The restriction of some flavored e-cigarette products has resulted in a shift of the sales and marketing of restricted flavored e-cigarette products toward other available flavored e-cigarette products.”

    “A more comprehensive approach that includes the consideration of disposables, refillable devices and other flavored e-cigarettes not covered by the current FDA guidance is needed to offer the most benefit for prevention efforts among youth and young adults,” the authors write.

    The FDA is expected to ban menthol-flavored products sometime this year.

  • Chinese Vapers Stocking up Ahead of Flavor Ban

    Chinese Vapers Stocking up Ahead of Flavor Ban

    Photo: Victor Moussa

    Vapers in China have reportedly been stocking up on flavored liquids in anticipation of a ban. A staff member at a RELX store in Shanghai told Sixth Tone that his shop had seen an increased demand for flavored pods since the government announcement, with grape and cola-flavored varieties selling out almost instantly.

    On March 11, the State Tobacco Monopoly Administration published the final “Management Rules for E-cigarettes,” which includes a ban on domestic sales of nontobacco-flavored e-cigarettes. The rules are scheduled to take effect May 1.

    The move was welcomed by anti-vaping groups such as the Campaign for Tobacco-Free Kids, which said the rule would help prevent children from becoming smokers. “Children who use e-cigarettes are more than twice as likely to use cigarettes in the future, according to the World Health Organization,” said Yolonda Richardson, executive vice president for the Campaign for Tobacco-Free Kids, in a statement. “China’s new policy is the right move to protect Chinese kids from these addictive products.”

    The flavor ban is part of a long list of new requirements for the vaping business. China’s new rules also ban refillable products and synthetic nicotine while limiting the strength of e-liquid to 20 mg/mL.

    Manufacturers, wholesalers and Chinese retailers will be required to conduct all business on a “unified national electronic cigarette transaction management platform,” and exports will be restricted to vapor products allowed in the destination countries.

    The new rules will force e-cigarette sellers like RELX to sell competitors’ brands in their Chinese stores—something they don’t do currently.

    With more than 300 smokers, China remains the world’s largest cigarette market, representing considerable potential for vapor companies. The country’s domestic e-cigarette market has grown at a rate of 70 percent a year since 2013, according to the Global Times, and is valued at about $1.3 billion.

    China exports $15.6 billion of vaping products annually, according to the Shanghai Daily.

  • China Mulls Ban on Flavored E-Cigarettes

    China Mulls Ban on Flavored E-Cigarettes

    Photo: Victor Moussa

    China will ban nontobacco flavors in e-cigarettes if an updated draft of standards for the vaping industry becomes law, reports Shine.

    In November 2021, China’s State Council amended the country’s tobacco monopoly law to include vapor products and requested public input on its proposed regulations for the segment.

    While the original proposal appeared to permit nontobacco flavors, the new draft, published on March 11, underlines the importance of reducing the appeal of e-cigarettes to youth, stating: “Flavors other than tobacco taste shall not be offered in products.” To be specific, 21 additives, referring to tastes like plum, rose and orange, are removed from the list.

    As some U.S. states and European countries already have flavor bans in place, industry experts believe the new regulations may have a greater impact on the domestic market rather than exports.

    In an interview with Securities Times, an unnamed industry insider said sales volumes of tobacco-flavored e-cigarettes in the domestic market are dwarfed by other flavors.

    The March 11 publication sent stocks of Chinese vapor companies tumbling. Shares of RLX Technology, which had just reported strong revenues for 2021, dropped more than 36 percent and closed at $1.49 on the New York Stock Exchange on Friday.

    The updated draft is now available on the State Tobacco Monopoly Administration’s website. The administration is asking for public feedback until March 17.